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NCT Number: NCT05069402

Impact of Various Diets on Surgical Complications

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Narodowy Instytut Onkologii, Krakow, Malopolska, Poland

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About this study

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Italian studies followed by metanalyses demonstrated the superiority of immunomodulating diets (IM) over any other preoperative nutrition, hence the surgical guidelines for enteral nutrition published by European Society for Clinical Nutrition and Metabolism (ESPEN) in 2006 recommended to use IM for 7-14 days preoperatively in all patients undergoing major surgeries. Some authors questioned IM by showing no benefit of IM over standard enteral nutrition. Other authors observed similar results.The debate was far from being over - in 2015 a new metanalysis stated that perioperative enteral nutrition is the best option for managing clinical status of patients who underwent selective surgery for gastrointestinal cancer. One year later, ESPEN changed its surgical recommendations and advised to use IM preoperatively in malnourished and perioperatively in well-nourished patients. American recommendations remained unchanged and, according to them, it is advised to use IM preoperatively in all surgical patients, however, high-protein nutrition could also be an beneficial option.

To address those doubts and to assess the actual clinical significance of oral immunonutrition, a randomized, two center, prospective clinical trial was conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (BMI) < 18),
  • good general status (Karnofsky Performance Index > 80,
  • Eastern Cooperative Oncology Group (ECOG) grade 0 or 1);
  • no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease [COPD], coronary aortic bypass graft [CABG], etc.),
  • no history of known allergies or drug intolerance to analyzed substances.

Exclusion criteria

  • Patients malnourished or with metastatic disease,
  • pregnant,
  • in poor general status (Karnofsky <80, Eastern Cooperative Oncology Group (ECOG) > 1),
  • recent history of severe heart, lung, kidney or liver failure,
  • history of allergies or drug intolerance

Treatment and study plan

Immunonutrition

Dietary Supplement

diet with immunonutrients

High-protein

Dietary Supplement

Oral nutrition with high-protein content

Standard ONS

Dietary Supplement

Oral nutrition with standard ingredients

Primary outcomes

  1. Surgical complications

    Time frame: 6 months

    Number and type of surgical complications

  2. Infectious complications

    Time frame: 6 months

    Number and type of infectious complications

Secondary outcomes

  1. Length of stay

    Time frame: 6 months

    Days of hospital stay after the operation

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

Impact of Immunomodulating Oral Nutrition on Surgical Complications

Acronym: IMM4

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2021
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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